Boston Scientific Recalls Encore 26 Inflation Devices Due to Cracked Trays
Boston Scientific is recalling 305,779 Encore 26 Inflation Devices worldwide because of complaints regarding cracked trays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites complaints of cracked trays without reporting any injuries, hospitalizations, or deaths. This aligns with the rubric for moderate severity involving low-risk defects or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Boston Scientific Corporation is recalling 305,779 units of the Encore(TM) 26 Inflation Device. The affected devices are identified by specific catalog numbers and serial numbers listed in the recall notice. The distribution pattern for these devices is worldwide.
The recall was initiated after Boston Scientific received complaints regarding cracked trays on the Encore device. The source text does not provide further details on the specific nature of the cracks or any reported injuries associated with this defect.
Healthcare providers and consumers should check their inventory for the specific serial numbers and catalog numbers listed in the official recall notice. If a device is found to be affected, it should be removed from use and returned to Boston Scientific or the distributor according to the company's instructions.
The recalled product
- Product
- Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 305,779
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: (a) 19563006
- 19587644
- 19623142
- 19650458
- 19704550
- 19725489
- 19769215
- 20054530
- 20077271
- 20083051
- 20127928
- 20159518
- 20202728
- 20206930
- 20242335
- 20285571
- 20309573
- 20309574
- 20336380
- 20394218
Distribution
Distribution scope not specified by the agency.
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